Revised requirements for combination products (medicinal products with a medical device component)
1 giugno 2021 – Since 26 May 2021, applications for the authorisation of integral combination products must demonstrate to Swissmedic that, unless it bears a valid CE certification mark, the medical device component satisfies the applicable basic safety and performance requirements of Annex I of the MDR. Furthermore, in keeping with Article 117 MDR, a “Notified Body Opinion” must be submitted for integral medical device products of classes Is, Im, Irsi, IIa, IIb and III that do not have a certification from one of the designated conformity assessment bodies (i.e. that do not have a CE certificate). These must be integrated into module 3.2.R.
As previously, the suitability of the medical device component for the specific medicinal product in the proposed combination must be demonstrated. The requirements in this regard can be found in the EMA guideline on combination products.
For more information, see here